- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07613944
Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders
Standardised Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disordered Breathing: a Research Protocol
Obstructive sleep-disordered breathing, including obstructive sleep apnea (OSA), represents a significant yet underdiagnosed condition in the pediatric population, particularly among adolescents with obesity. The tongue is a central anatomical contributor to upper airway collapsibility; however, its biomechanical properties have been investigated almost exclusively in adult populations, leaving a critical gap in knowledge regarding younger individuals.
This study aims to assess tongue biomechanical and echographic characteristics using quantitative ultrasound modalities - shear-wave elastography (SWE), acoustic attenuation, and echo intensity - in adolescents aged 12 to 18 years with obesity and obstructive sleep disorders. The study adopts a mixed design combining (1) an observational cross-sectional comparison between participants with obesity and OSDB and age- and sex-matched healthy controls at baseline, and (2) a prospective longitudinal cohort component evaluating changes in tongue ultrasound characteristics over the course of a 30-week multidisciplinary inpatient weight-loss program delivered as standard care at the Zeepreventorium (De Haan, Belgium). An additionnal methodological objective consists in determining intra-rater and inter-rater reliability of the ultrasound acquisition protocol providing a reproducible framework for future studies.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Scientific Background and Rationale Amongst obstructive sleep disorders, Obstructive sleep apnea (OSA) is characterized by repetitive complete (apnea) or partial (hypopnea) collapse of the upper airway during sleep. Upper airway collapsibility in OSA results from the interaction of multiple contributing mechanisms, including craniofacial morphology (retrognathia, maxillary constriction, reduced posterior airway space), adenotonsillar hypertrophy - a predominant anatomical risk factor in the pediatric population -, obesity-related peripharyngeal fat deposition, neuromuscular control deficits of upper airway dilator muscles, and environmental exposures such as prenatal or passive tobacco smoke exposure, associated with increased upper airway inflammation and altered respiratory control.
Among the anatomical structures implicated in upper airway collapsibility, the tongue plays a central role as the largest muscular structure of the oropharynx. Morphological and biomechanical alterations (incl. increased volume, fat infiltration at the base, posterior positioning, and modified tissue stiffness) have been identified as relevant contributors to airway obstruction and are increasingly investigated as potential screening markers.
In the pediatric population, OSA remains substantially underdiagnosed. Access to polysomnography is limited, parents seldom spontaneously report nocturnal symptoms, and prevalence estimates vary widely in the literature (1.2% to over 60% in children with obesity), partly due to heterogeneous diagnostic criteria. This epidemiological uncertainty underscores the need for accessible, non-invasive tools capable of characterizing tongue biomechanical properties in younger populations - a gap that the present study directly addresses.
Ultrasound is non-invasive, non-ionizing, widely accessible, and well tolerated, including in adolescents. Existing studies applying these modalities to the tongue in OSA have been conducted exclusively in adult populations and report heterogeneous, sometimes contradictory findings. Methodological variability in acquisition parameters, probe positioning, and region-of-interest definition substantially limits reproducibility and inter-study comparability. No study to date has applied this multimodal quantitative ultrasound approach to adolescents with obesity and obstructive sleep-disordered breathing, nor examined the longitudinal trajectory of these parameters in response to a structured weight-loss intervention. The present study is therefore the first to address this population and this clinical question.
Tongue morphology and tongue fat in patients suffering from OSA have been assessed several times with ultrasound, a non-invasive, widely accessible imaging modality that provides real-time visualization of tissues and is generally well tolerated, with minimal to no associated discomfort. Ultrasound echo intensity has been validated with MRI to estimate tongue fat percentage. Advanced ultrasound modalities, such as shear wave elastography (SWE) and attenuation imaging (AI), provide quantitative measures of tissue stiffness and its attenuation properties, respectively Existing studies on tongue SWE and echo intensity (EI) have been conducted exclusively in adults and report heterogeneous, and sometimes contradictory, findings in patients suffering from OSA. Raw data in EI values would increase in the case of high lipidic impregnation or fibrous accumulation and decrease when the amount of muscle is higher, but the results are still variable depending on the location. Methodological variability in acquisition parameters, probe positioning, region-of-interest definition, and data analysis substantially limit reproducibility and comparability. Arbitrary region-of-interest sizing that does not account for individual tongue morphology may further introduce systematic bias.
Another gap in current research is the limited focus on younger populations. While studies have primarily targeted middle-aged and older adults due to the higher prevalence of OSA in these groups, the biomechanical properties of the tongue may differ significantly in younger individuals, due to growth and hormonal factors. In particular, heterogeneous distribution of elasticity values between anterior and posterior regions of the tongue indicate that there is a need for a better understanding The objectives of this study and anticipated new evidence are as follows below. Primary objective: to compare tongue biomechanical properties, assessed using shear-wave elastography and quantitative ultrasound, between children and adolescents with obesity and obstructive sleep disorders and age-matched healthy controls.
Secondary objectives: (1) to assess longitudinal changes in tongue echographic characteristics over the course of a 30-week multidisciplinary weight-loss program delivered as part of standard care and (2) to evaluate the influence of anthropometric parameters, sex, and pubertal status on these measurements.
Methodological objective: to determine the intra-rater and inter-rater reliability of ultrasound-based tongue measurements, thereby providing a reproducible framework for future clinical and comparative studies.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Frederic Paillaugue, MSc PT
- Numero di telefono: +32485952930
- Email: frederic.paillaugue@vub.be
Luoghi di studio
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Brussels, Belgio, 1090
- KidZ Health Castle - Universitair Ziekenhuis Brussel Brussels - Health Campus Avenue du Laerbeek 101 1090 Jette
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Contatto:
- Frederic Paillaugue, MSc PT
- Numero di telefono: +32485952930
- Email: frederic.paillaugue@vub.be
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Contatto:
- Inge Gies, MD
- Numero di telefono: +324774111
- Email: inge.gies@uzbrussel.be
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Investigatore principale:
- Steven Provyn, Prof PhD
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De Haan, Belgio, 8420
- Zeepreventorium, Koninklijke Baan 5, 8420 De Haan
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Contatto:
- Frederic Paillaugue, MSc PT
- Numero di telefono: +32485952930
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Investigatore principale:
- Steven Provyn, Prof PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Aged 12-18 years
- Already enrolled in Zeepreventorium weight-loss program as Standard Care Diagnosed Obstructive Sleep Apnea (AHI ≥ 1)1 or any Obstructive sleep disordered breathing detected by any of the specific sleep questionnaire (OSA-18, ESS, SSS-Ad, PDSS)
Exclusion Criteria:
- Any other orthopedic, traumatic, or rheumatologic condition affecting the cervicocephalic region
- Syndromic or neuromuscular disorders
- Cognitive impairment limiting compliance with study procedures
- Inability to provide informed consent
- Self-reported alcohol or recreational drug consumption within 48 hours preceding the experimental session
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Study group
Adolescents (12-18 y.o.) with obesity and sleep-disordered breathing, recruited at the Zeepreventorium de Haan and at the KidZ Health Castle UZ-VUB. The intervention will consist of a submental ultrasound examination - a pain-free, non-ionizing, and non-invasive imaging procedure - aimed at quantifying tongue biomechanical properties, complemented by the collection of descriptive and anthropometric measures including standing height, body weight, impedance analysis, and neck circumference. |
Tongue ultrasound via a submental approach.
This non-invasive, pain-free and non-radiating protocol will study both morphological and dynamic characteristics of the tongue.
Ultrasonographic assessment will be performed with participants in a resting, supine position and ultrasound gel will be used to optimise submental probe contact.
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Comparatore attivo: Control group
A control group of healthy participants (without obesity nor sleep disorders), matched for gender and age, will be recruited from among the researchers' acquaintances.
The intervention will be the same, consisting of a submental ultrasound examination - a pain-free, non-ionizing, and non-invasive imaging procedure - aimed at quantifying tongue biomechanical properties, complemented by the collection of descriptive and anthropometric measures including standing height, body weight, impedance analysis, and neck circumference.
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Tongue ultrasound via a submental approach.
This non-invasive, pain-free and non-radiating protocol will study both morphological and dynamic characteristics of the tongue.
Ultrasonographic assessment will be performed with participants in a resting, supine position and ultrasound gel will be used to optimise submental probe contact.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Rigidità della lingua
Lasso di tempo: al basale e dopo un programma di perdita di peso di 30 settimane
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La rigidità della lingua viene misurata tramite elastografia a onde di taglio e espressa in kPa.
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al basale e dopo un programma di perdita di peso di 30 settimane
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Spessore della lingua
Lasso di tempo: al basale e dopo 30 settimane di programma di perdita di peso
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Lo spessore della lingua (espresso in cm) sarà misurato con l'ecografia come la distanza perpendicolare dalla fascia profonda del muscolo genioioideo al più alto dorso linguale nel piano mediano sagittale
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al basale e dopo 30 settimane di programma di perdita di peso
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Intensità dell'Eco
Lasso di tempo: al basale e dopo un programma di perdita di peso di 30 settimane
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L'intensità dell'eco sarà misurata con il software ImageJ / Fiji (ImageJ, US NIH, Bethesda, USA) e si riferisce al valore medio dei pixel di un'area, basato su una scala di grigi compresa tra 0 (nero) e 255 (bianco)
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al basale e dopo un programma di perdita di peso di 30 settimane
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Acoustic Attenuation
Lasso di tempo: at baseline and after a 30 weeks weight loss program
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Attenuation will be measured with ultrasound and depicts the quantitative measurement of ultrasound attenuation in tissues.
It is expressed as an attenuation coefficient in dB/cm/MHz.
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at baseline and after a 30 weeks weight loss program
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Coefficiente di correlazione intraclasse, ICC
Lasso di tempo: Baseline
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Il coefficiente di correlazione intraclasse sarà utilizzato per valutare l'affidabilità intra e inter-valutatore dei marcatori ecografici. L'affidabilità e la ripetibilità ecografica delle misurazioni della lingua saranno valutate con coefficienti di correlazione intraclasse (ICC), insieme ai loro intervalli di confidenza al 95%.
Ogni misurazione ecografica (dimensioni della lingua e parametri morfologici, intensità dell'eco, rigidità, imaging dell'attenuazione tissutale, imaging della distribuzione dello scattering tissutale e frazione di grasso) nei piani sagittale e coronale sarà eseguita due volte in quindici partecipanti dal ricercatore principale, con un intervallo di 24 ore tra gli esami.
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Baseline
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Peso
Lasso di tempo: baseline e dopo un programma di perdita di peso di 30 settimane
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Il peso verrà misurato con una bilancia Tanita e espresso in kg
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baseline e dopo un programma di perdita di peso di 30 settimane
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Altezza
Lasso di tempo: Baseline e dopo un programma di perdita di peso di 30 settimane
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L'altezza sarà misurata con uno stadiometro e espressa in cm
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Baseline e dopo un programma di perdita di peso di 30 settimane
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OSA-18 questionnaire
Lasso di tempo: Baseline and after a 30-weeks weight loss program
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The OSA-18 is a disease-specific screening tool for early diagnosis of obstructive sleep apnea in children, and is used to evaluate the quality of life before and after treatment. The Obstructive Sleep Apnea - 18 questionnaire is specific to obstructive sleep apnea in children and will be used for correlation analysis. Quality of life is assessed using the Obstructive Sleep Apnea - 18 Quality of Life Survey (OSA-18), a validated questionnaire comprising 18 items. Total scores range from 18 to 126, with higher scores indicating poorer quality of life and greater disease impact, and lower scores reflecting better outcomes. |
Baseline and after a 30-weeks weight loss program
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Stanford Sleepiness Scale (for adolescents)
Lasso di tempo: Baseline and after a 30-weeks weight loss program
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The Stanford Sleepiness Scale (SSS) is a single-item, momentary self-report scale assessing current level of alertness and sleepiness on a 7-point ordinal scale, ranging from 1 ("feeling active, vital, alert, or wide awake") to 7 ("no longer fighting sleep, sleep onset soon, having dream-like thoughts").
Originally developed by Hoddes et al. (1973), the scale captures state sleepiness at a given moment rather than habitual sleepiness patterns, making it particularly suitable for repeated within-session assessments.
Its adaptation and use in adolescent populations has been documented in pediatric sleep research, where it complements trait-level instruments such as the ESS and PDSS.
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Baseline and after a 30-weeks weight loss program
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Pediatric Daytime Sleepiness Scale (PDSS)
Lasso di tempo: Baseline and after a 30-weeks weight loss program
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The Pediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-report questionnaire designed to assess daytime sleepiness in school-aged children and adolescents.
Each item is rated on a 5-point Likert scale (0-4), yielding a total score ranging from 0 to 32, with higher scores indicating greater daytime sleepiness.
The PDSS was developed and validated by Drake et al. (2003) and has demonstrated adequate internal consistency (Cronbach's α = 0.78) and convergent validity with objective sleep measures.
It is specifically designed for pediatric populations and captures sleep-related daytime impairment across academic, behavioral, and social domains.
A score ≥ 15 has been proposed as a clinically meaningful threshold for excessive daytime sleepiness in adolescents.
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Baseline and after a 30-weeks weight loss program
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Epworth Sleepiness Scale (ESS)
Lasso di tempo: Baseline and after a 30-weeks weight loss program
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The Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire assessing the propensity to fall asleep across eight everyday situations, rated on a 4-point Likert scale (0-3), yielding a total score ranging from 0 to 24.
Higher scores reflect greater subjective daytime sleepiness.
Originally developed and validated by Johns (1991) in adults, the ESS has been subsequently validated for use in adolescent populations and is among the most widely used instruments for screening excessive daytime sleepiness in clinical and research settings.
A score > 10 is conventionally considered indicative of excessive daytime sleepiness.
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Baseline and after a 30-weeks weight loss program
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BMI Z-score
Lasso di tempo: Baseline and after a 30-weeks weight loss program
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The body mass index Z-score (BMI Z-score, also referred to as BMI standard deviation score) is a age- and sex-standardized measure of body mass index (BMI, kg/m²) that expresses an individual's BMI relative to a reference population of the same age and sex.
It is calculated as the deviation of an individual's BMI from the median BMI of the reference population, expressed in units of standard deviation.
In pediatric populations, the BMI Z-score is the recommended metric for assessing adiposity and defining weight status categories, as raw BMI values are not directly comparable across age and sex groups due to physiological changes in body composition during growth.
In the present study, BMI Z-scores will be calculated according to the World Health Organization (WHO) 2007 reference data for school-aged children and adolescents (5-19 years).
Obesity is defined as a BMI Z-score > +2 SD, and overweight as a BMI Z-score between +1 SD and +2 SD above the age- and sex-specific median.
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Baseline and after a 30-weeks weight loss program
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Brockmann, P., & Gozal, D. (2022). Neurocognitive Consequences in Children with Sleep Disordered Breathing: Who Is at Risk? Children, 9(9), 1278. https://doi.org/10.3390/children9091278 Chu, C.-A., Chen, Y.-J., Chang, K.-V., Wu, W.-T., & Özçakar, L. (2021). Reliability of Sonoelastography Measurement of Tongue Muscles and Its Application on Obstructive Sleep Apnea. Frontiers in Physiology, 12, 654667. https://doi.org/10.3389/fphys.2021.654667 da Silva Gusmão Cardoso, T., Pompéia, S., & Miranda, M. C. (2018). Cognitive and behavioral effects of obstructive sleep apnea syndrome in children: A systematic literature review. Sleep Medicine, 46, 46-55. https://doi.org/10.1016/j.sleep.2017.12.020 Gipson, K., Lu, M., & Kinane, T. B. (2019). Sleep-Disordered Breathing in Children. Pediatrics in Review, 40(1), 3-13. https://doi.org/10.1542/pir.2018-0142 Glicksman, A., Hadjiyannakis, S., Barrowman, N., Walker, S., Hoey, L., & Katz, S. L. (2017). Body Fat Distribution Ratios and Obstructive Sleep Apnea Severity in Youth With Obesity. Journal of Clinical Sleep Medicine: JCSM: Official Publication of the American Academy of Sleep Medicine, 13(4), 545-550. https://doi.org/10.5664/jcsm.6538 Halbower, A. C., Degaonkar, M., Barker, P. B., Earley, C. J., Marcus, C. L., Smith, P. L., Prahme, M. C., & Mahone, E. M. (2006). Childhood Obstructive Sleep Apnea Associates with Neuropsychological Deficits and Neuronal Brain Injury. PLoS Medicine, 3(8), e301. https://doi.org/10.1371/journal.pmed.0030301 Yu, J. L., Wiemken, A., Schultz, S. M., Keenan, B. T., Sehgal, C. M., & Schwab, R. J. (2022). A comparison of ultrasound echo intensity to magnetic resonance imaging as a metric for tongue fat evaluation. Sleep, 45(2), zsab295. https://doi.org/10.1093/sleep/zsab295
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- 26137_EchoTongue
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